Project Lead – Clinical Research

About the role

The Clinical Research Unit (CRU) at the Montreal Neurological Institute‑Hospital is seeking a Project Lead to design, launch, and oversee investigator‑initiated clinical studies in adult neuroscience. Reporting to the CRU leadership, the Project Lead will collaborate with investigators, academic partners, funding agencies, industry sponsors, and vendors to ensure high‑quality research delivery.

Key responsibilities

• Manage end‑to‑end clinical research projects within the Neuro CRU.
• Design and write study protocols in close partnership with investigators and external collaborators.
• Prepare and submit grant proposals, ensuring alignment with university and sponsor policies.
• Coordinate REB applications and, when required, regulatory submissions to Health Canada or the FDA.
• Define operating procedures, timelines, and logistics for sample processing, data collection, and participant recruitment.
• Develop study budgets, negotiate contracts, and oversee financial aspects with internal and external partners.
• Monitor sponsor‑related activities, including data quality control, interim analyses, and multi‑site coordination.
• Document project outcomes, produce detailed reports, and communicate results to physicians, funding bodies, and industry partners.
• Provide training to new Clinical Research Coordinators on internal protocols.

Required profile

• Proven experience managing clinical research projects, preferably in neuroscience or related fields.
• Strong ability to design and write investigator‑initiated study protocols.
• Familiarity with grant writing, REB submission processes, and regulatory requirements (Health Canada, FDA).
• Excellent organizational skills to coordinate multiple project activities and timelines.
• Effective communication skills for interaction with investigators, sponsors, and multidisciplinary teams.

Required skills

• Electronic data capture systems
• Data quality control